Simplifying Survivorship Care Planning

BACKGROUND: Each year, approximately 1.6 million people are diagnosed with cancer and the
relative 5-year survival rate across all cancer types approaches 70%. As of 2014, there were
almost 15 million Americans living with a history of cancer. Cancer survivors face a variety
of health care needs, including surveillance for recurrence, treatment for long-term and late
effects of cancer and its treatment, general primary and preventive care, management of any
comorbidities, encouragement of healthy lifestyle behaviors, and attention to psychosocial
issues. In 2005, the Institute of Medicine (IOM) report 'From Cancer Patient to Cancer
Survivor: Lost in Transition' highlighted the challenges that cancer survivors face as they
transition from acute treatment. The completion of acute cancer treatment is a critical
juncture at which patients are in need of better support and communication to ensure optimal
health and quality of life outcomes as they transition to long-term survivorship. Cancer
survivors face substantial deficiencies in the quality of care that they receive, including
both underuse of recommended care and overuse of services that are not recommended for
routine follow-up. The 2005 IOM report called for all patients completing acute treatment to
be provided with a survivorship care plan (SCP) that summarizes treatments received and
outlines future healthcare priorities in order to facilitate effective management of health
care between survivors and their oncology and primary care providers.

STUDY PROCEDURES: The primary aim of this trial is to assess whether there is a difference
among three SCP models of varying levels of resource intensity and patients' receipt of
recommended health services in the months following completion of acute treatment. The
investigators will conduct a randomized controlled trial (RCT) to measure whether the
provision of the SCP to the survivor and primary care provider (PCP) is associated with
survivors' receipt of cancer follow-up care as outlined on their SCP (primary outcome).
Avoidance of non-recommended care, receipt of recommended primary and preventive care, and
patient-reported outcome measures will serve as secondary endpoints.

Participants in the RCT will have been treated for breast, prostate, or colorectal cancer.
This RCT will be conducted in four oncology clinics in two medical systems. The investigators
will enroll survivors of Stage I-III breast, prostate, or colorectal cancer who are
completing treatment and transitioning to long-term survivorship, and use a stratified
randomization to assign participants to one of three study conditions (Arms A, B or C). This
study will focus specifically on the period following completion of acute treatment (e.g.,
surgery, radiation, and chemotherapy); patients receiving long-term adjuvant
endocrine/antibody therapies will also be eligible.

The proposed trial will be conducted at Johns Hopkins Medical Institution (JHMI) and
Peninsula Regional Medical Center (PRMC). JHMI is a large, academic medical center in an
urban setting with distinct treatment programs based on disease site. At JHMI, the
investigators will recruit from the Breast Cancer Program, the Genitourinary Cancer Program
(prostate cancer), and Gastrointestinal Cancer Program (colorectal cancer). These programs
operate across disciplines (e.g., medical, radiation, and surgical oncology) but separately
from each other, enabling evaluation of 3 separate clinical settings within JHMI. In
addition, the trial will include the PRMC Richard A. Henson Cancer Institute, a community
cancer program located in the rural area of Maryland's eastern shore. At PRMC there is a
single general oncology practice. The four programs differ in the extent to which
survivorship care planning is already a part of routine care. As yet, none of the clinics in
this study has a consistent format for the delivery of SCP universally at the completion of
acute treatment. The study design (cancer types, clinical systems and SCP models) is intended
to enable the development of real-world best practices for the implementation of SCPs and
assess whether these are consistent or vary across a wide range of clinical contexts and
survivor characteristics.

Each participant will be followed for 18 months, with the number of visits dependent on the
randomization arm (described below). The investigators will abstract 18 months of follow-up
data for enrolled patients from medical records, as well as from patient reports of health
service use; data will be collected at months 6, 12, and 18. The investigators will obtain
and abstract medical records guided by the information in the summary document (see Health
Services Use Summary included as a supplemental study document) and from the patient using
provided tracking tools of providers they have seen, tests they have undergone, etc. (see Tip
Sheet in supplemental study documents). Patient-reported outcomes will be collected at
baseline, 6, 12, and 18 months primarily via a REDCap form, with telephone or in-person data
collection as a back-up when needed.

Inclusion Criteria:

- Age 21 years or older;

- Diagnosed with breast, colorectal, or prostate cancer (stages I-III);

- Treated with intent to cure

- People who are on long-term (>1 year) chronic treatment are eligible;

- No evidence of disease;

- Able to complete the study data collection in English;

- Had their cancer care primarily managed by either JHMI or PRMC, with JHMI or PRMC
primarily responsible for the patients' survivorship care; and

- Has private insurance, or covered by Medicare or Medicaid.

Exclusion Criteria:

- Younger than 21 years of age;

- Diagnosed with in situ or metastatic breast, prostate or colorectal cancer (i.e. Stage
0 or IV);

- Not treated with intent to cure;

- Did not have cancer care primarily managed within one of the 4 participating clinics,
or JHMI or PRMC is not primarily responsible for the patients' survivorship care; and

- Does not have health insurance at screening.